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M-5276-559C 5
pacemaker. Patients who experience inadvertent complete AV block as a
result of RF ablation may also require permanent pacing.
9. During the trans-aortic approach, adequate fluoroscopic visualization is
necessary to avoid placement of the catheter in the coronary vasculature.
Intracoronary placement of the ablation catheter, RF energy application, or
both have been associated with myocardial infarction.
10. Minimize X-ray exposure during the procedure. Catheter ablation
procedures present the potential for significant X-ray exposure, which can
result in acute radiation injury as well as increased risk for somatic and
genetic effects, to both patients and laboratory staff due to the X-ray beam
intensity and duration of the fluoroscopic imaging. Catheter ablation should
only be performed after adequate attention has been given to the potential
radiation exposure associated with the procedure, and steps have been
taken to minimize this exposure. Careful consideration must therefore be
given for the use of the device in pregnant women.
11. Do not expose catheter to organic solvents such as alcohol.
12. Do not autoclave the catheter.
13. Do not immerse proximal handle or cable connector in fluids; electrical
performance could be affected.
14. Do not scrub or twist the distal tip electrode during cleaning.
15. Inspect irrigation saline for air bubbles prior to its use in the procedure. Air
bubbles in the irrigation saline may cause emboli.
16. Purge catheter and irrigation tubing with heparinized normal saline.
17. Electrophysiology catheters and systems are intended for use only in X-ray
shielded rooms due to electromagnetic compatibility requirements and other
hospital safety guidelines.
18. Do not attempt to operate the
Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter or the RF generator prior to completely reading and
understanding the applicable instructions for use.
19. Cardiac ablation procedures should be performed by appropriately trained
personnel in a fully equipped electrophysiology laboratory. Appropriate
clinical instruction in the use of the EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation Deflectable Tip Catheter should also be completed.
20. The long-term risks of protracted fluoroscopy and creation of RF induced
lesions have not been established. Careful consideration must therefore be
given for the use of the device in prepubescent children. Furthermore, the
risk/benefit in asymptomatic patients has not been studied.
21. To avoid thromboemboli, intravenous heparin should be used when entering
the left heart during ablation, and many physicians prescribe aspirin, less
often warfarin, for about 3 months afterward. No consensus yet exists about
the need for short-term anticoagulation after ablation.
22. When using the Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation Deflectable Tip Catheter with conventional systems
(using fluoroscopy to determine catheter tip location), or with the C
ARTO
®
EP
Navigation System, careful catheter manipulation must be performed in
order to avoid cardiac damage, perforation, or tamponade. Catheter
advancement should be done under fluoroscopic guidance. Do not use
excessive force to advance or withdraw the catheter when resistance is
encountered. The firmness of the braided tip dictates that care must be
taken to prevent perforation of the heart.
23. Always place the Rocker Lever in the neutral position to straighten the
catheter tip before insertion or withdrawal of the catheter.
24. Always maintain a constant heparinized normal saline infusion to prevent
coagulation within the lumen of the catheter.
25. When RF current is interrupted for either a temperature or an impedance
rise (the set limit is exceeded), the catheter should be removed, and the tip
cleaned of coagulum, if present. When cleaning the tip electrode, be careful
not to twist the tip electrode with respect to the catheter shaft; twisting may
damage the tip electrode bond and loosen the tip electrode. Make sure the
irrigation holes are not plugged prior to re-insertion.
26. Apparent low power output, high impedance reading, or failure of the
equipment to function correctly at normal settings may indicate faulty
application of the indifferent electrode(s) or failure of an electrical lead. Do
not increase power before checking for obvious defects or misapplication of
the indifferent electrode or other electrical leads.
27. Read and follow the indifferent electrode manufacturer’s instructions for use;
the use of indifferent electrodes that meet or exceed ANSI/AAMI
requirements (HF18), is recommended (e.g. the 3M Model 1149F or Valley
Lab Model 7505).
28. The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter is intended for use with compatible RF generators,
C
ARTO
®
EP Navigation System and Biosense Webster cables, and other
appropriate interface cables and connectors.
29. The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter has been shown to create larger lesions than
standard RF ablation catheters. Care should be taken when ablating near
structures such as the sino-atrial and atrioventricular nodes.
30. The sterile packaging and catheter should be inspected prior to use. Do not
use if the packaging or catheter appears damaged.
31. The catheter is sterilized with ethylene oxide gas and should be used by the
“Use By” date on the device package. Do not use the catheter if past the
“Use By” date.
32. The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter is intended for single patient use only.
33. Do not resterilize and reuse.
34. This device is packaged and sterilized for single use only. Do not reuse,
reprocess or resterilize. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/or lead to device failure
that in turn may result in patient injury, illness or death. Also, reprocessing or
resterilization of single use devices may create a risk of contamination
and/or cause patient infection or cross-infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness, or death of the
patient.
35. Do not use near MRI equipment since movement or heating of the catheter
may occur and the image on the display may become distorted.
36. Use both fluoroscopy and electrogram data to monitor catheter
advancement and reduce risk of tissue injury.
37. The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter used in conjunction with a RF generator is capable
of delivering significant electrical power. Patient or operator injury can result
from improper handling of the catheter and indifferent electrode, particularly
when operating the catheter. During energy delivery, the patient should not
be allowed to come in contact with grounded metal surfaces. If during
ablation, temperature does not rise, discontinue delivery of energy and
check set-up.
38. The risk of igniting flammable gases or other materials is inherent in
electrosurgery. Precautions must be taken to restrict flammable materials
from the electrosurgical suite.
39. Electromagnetic interference (EMI) produced by the
Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter, when used in conjunction with an RF generator
during normal operation, may adversely affect the performance of other
equipment.
40. Electrodes and probes for monitoring and stimulating devices can provide
paths for high frequency current. The risk of burns can be reduced but not
eliminated by placing the electrodes and probes as far away as possible
from the ablation site and the indifferent electrode. Protective impedances
may reduce the risk of burns, and permit continuous monitoring of the
electrocardiogram during energy delivery.
WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
